Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B

May 3, 2012 updated by: Novartis Pharmaceuticals

A Single-arm, Multicenter, Open-label, 52-week Treatment, Extension Study to CLDT600ACN04 Study to Evaluate the Efficacy (Including Histological Improvement) and Safety in Fourth to Sixth Year of Telbivudine Treatment in Patients With Chronic Hepatitis B

The purpose of this trial is to provide data of absence of inflammation in patient liver histology after long-term telbivudine treatment and thus help investigators to make a comprehensive judgment on treatment discontinuation in selected patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Ditan Hospital
      • Peking, China
        • First Hospital of Peking University
      • Peking, China
        • Peking University People's Hospital
      • Shanghai, China
        • Ruijin Hospital, Affiliated to 2nd Medical university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient completed study CLDT600ACN04 study and will be available to immediately rollover into this study without discontinuation of study drug.
  • Patient was not discontinued from the previous CLDT600ACN04 study.
  • Adult patients with CHB (HBeAg positive or HBeAg negative).
  • HBV DNA PCR undetectable in recent 12 months.

Exclusion Criteria:

  • Pregnant or breastfeeding, or has plan of pregnant during study period.
  • Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV at screening visit.
  • Patient has received within the past 12 months any anti-HBV treatment combination (add-on therapy) or switch to other anti HBV treatment from Telbivudine at investigator's discretion.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: telbivudine/LDT600

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess proportion of patients with absence of inflammation in liver biopsy at study entry and combine the histological assessment with serological evaluations.
Time Frame: Visit 2 (week 1)
Visit 2 (week 1)

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the HBV DNA PCR negativity at 4th-6th year treatment with telbivudine (LDT), in selected patients who have completed study CLDT600ACN04 and will continue telbivudine treatment
Time Frame: weeks 1, 24, 52 and 24 weeks post-treatment
weeks 1, 24, 52 and 24 weeks post-treatment
To evaluate the percentage of patients with HBeAg loss and/or gain of detectable level of HBeAb in HBeAg positive CHB at baseline of NV-02B-007 or NV-02B-015 studies
Time Frame: weeks 24 and 52, 24 weeks post-treatment
weeks 24 and 52, 24 weeks post-treatment
To evaluate percentage of patients with with HBsAg loss and/or HBsAg seroconversion
Time Frame: weeks 24, 52 and 24 weeks post-treatment
weeks 24, 52 and 24 weeks post-treatment
To evaluate the changes in Knodell inflammatory and fibrosis scores from biopsy at study entry compared to biopsy at baseline of studies NV-02B-007 and NV-02B-015
Time Frame: Visit 2 (week 1)
Visit 2 (week 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

April 6, 2009

First Submitted That Met QC Criteria

April 6, 2009

First Posted (Estimate)

April 7, 2009

Study Record Updates

Last Update Posted (Estimate)

May 4, 2012

Last Update Submitted That Met QC Criteria

May 3, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLDT600ACN04E1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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